Affinia Therapeutics, a gene therapy company with a pipeline of adeno-associated virus (AAV) gene therapies for cardiovascular and neurological diseases, and Forge Biologics, a manufacturer of genetic medicines, entered an agreement to tech transfer and manufacture clinical trial material under cGMP to help advance Affinia’s pipeline of development candidates into clinical trials. 
 
The scope includes Affinia’s investigational medicine program, AFTX-201 for BAG3 dilated cardiomyopathy, a devastating monogenic heart disease affecting more than 70,000 patients in the U.S., Europe, and U.K. regions.
 
Affinia’s pipeline of gene therapies incorporate the company’s novel tissue-tropic AAV capsids validated in single-clonal nonhuman primate studies and the company’s plasmid design system validated across a range of novel and conventional capsids and payloads. These innovations are designed to enable the targeted delivery of genetic payloads to tissues of interest, improving efficacy, safety, and cost of goods, as well as the potential treatment of prevalent diseases with first-in-class or best-in-class therapies. The company’s initial programs are intended to address cardiovascular or neurological diseases.
 
Through this partnership, Forge will provide tech transfer services, process and analytical development, toxicology, and cGMP manufacturing services to Affinia. All tech transfer, development, and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, OH.
 
“We’re proud to support Affinia’s vision of bringing hope to patients affected by cardiomyopathy through their innovative gene therapy,” said John Maslowski, President and CEO of Forge. “Forge’s comprehensive AAV development and manufacturing services, including our robust tech transfer capabilities, were designed to empower partners like Affinia as they work to deliver transformative therapies to patients worldwide.”
 
“We are pleased to enter into this tech transfer and manufacturing partnership with an initial focus on AFTX-201 utilizing our proprietary cardiac capsid and plasmid design,” said Rob May, Affinia’s Chief Technical Operations Officer. “We are delighted with Forge’s expertise, strong collaboration, and industry-leading capabilities that were evident during the tech transfer process. We look forward to advancing our innovative pipeline of rationally designed gene therapies toward the clinic jointly with Forge.”